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NCT Number: NCT04269629

The Effect of Antihypertensive Drugs on Severity of Anaphylaxis and Side-effects During Venom Immunotherapy

There is an ongoing debate whether antihypertensive treatment with beta-blockers and/or angiotensin converting Enzyme (ACE)-inhibitors comprises a risk factor for more severe and more frequent side-effects during venom immunotherapy (VIT). In the literature, data are controversial and originate from case reports or statistically underpowered studies; the number of included patients was usually high but the proportion of patients on antihypertensive treatment was low ranging from 2-11%.

The study was conducted as a prospective, observational, European multicenter study. 1425 patients, aged from 35 to 85 years, with a history of an anaphylactic reaction due to bee or wasp stings, were included. The medical history was recorded as well as laboratory parameters and data of the VIT-updosing phase. One year after reaching the maintenance dose, possible side-effects during VIT as well as the outcome of field stings or sting challenges were documented.

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Key information

Conditions

Hymenoptera Venom Allergy Antihypertensive Treatment

Age range

35 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Dermatology and Venerology, Medical University of Graz

Graz, 8036, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • History of systemic sting reaction (≥ grade I according the classification by Ring and Messmer)
  • age 35 to 85 years

Exclusion criteria

  • absolute contraindications for VIT
  • pretreatment with Omalizumab

Treatment and study plan

Insect Venom

Drug

Patients receive insect venom immunotherapy. The frequency of systemic side-effects is recorded and compared between patients under antihypertensive treatment and patients not taking antihypertensive drugs.

Primary outcomes

  1. Frequency of Side Effects (=Systemic Reaction, SR) During Venom Immunotherapy (VIT)

    Time frame: after finishing the updosing phase (duration up to 6 months depending on the updosing protocol chosen by the patient) of a patient's venom immunotherapy; duration of Visit ~1hour

    The primary objective of this study is to evaluate whether subjects under antihypertensive treatment with beta-blockers and/or angiotensin converting enzyme (ACE)-inhibitors show more side effects during VIT compared to subjects with no antihypertensive treatment.

Secondary outcomes

  1. Severity of Sting Reactions

    Time frame: duration of first visit (~1hour)

    To evaluate whether subjects under antihypertensive treatment with beta-blockers and/or ACE-inhibitors have more severe sting reactions.

  2. Correlation of the Prevalence of Cardiovascular Diseases and/or Hypertension With the Risk for More Severe Systemic Sting Reactions.

    Time frame: duration of first visit (~1hour)

    To correlate the prevalence of cardiovascular diseases and/or hypertension with the risk for more severe systemic sting reactions.

  3. Association of Bee Venom With a Higher Frequency of Side-effects (=Systemic Reaction, SR).

    Time frame: after finishing the updosing phase (duration up to 6 months depending on the updosing protocol chosen by the patient) of a patient's venom immunotherapy; duration of Visit ~1hour

    To evaluate whether bee venom is associated with a higher frequency of side-effects.

  4. Correlation of High Specific Immunoglobulin E (sIgE) Levels to a Higher Frequency of Side-effects (=Systemic Reaction, SR).

    Time frame: after finishing the updosing phase (duration up to 6 months depending on the updosing protocol chosen by the patient) of a patient's venom immunotherapy; duration of Visit ~1hour

    To evaluate whether high specific immunoglobulin E (sIgE) levels are correlated to a higher frequency of side-effects.

    sIgE levels are expressed in kilo units/liter [kU/L].

  5. Correlation of High Tryptase Levels to a Higher Frequency of Side-effects (=Systemic Reaction, SR).

    Time frame: after finishing the updosing phase (duration up to 6 months depending on the updosing protocol chosen by the patient) of a patient's venom immunotherapy; duration of Visit ~1hour

    To evaluate whether high tryptase levels are correlated to a higher frequency of side-effects

  6. Correlation of Quicker Up-dosing Protocols to a Higher Frequency of Side-effects (=Systemic Reaction, SR).

    Time frame: depends on the protocol used for venom immunotherapy, a maximum of about 6 months

    To evaluate whether quicker up-dosing protocols are correlated to a higher frequency of side-effects.

  7. Efficacy of VIT

    Time frame: 1 year after reaching the maintenance dose; duration of Visit ~1hour

    The outcome (systemic reaction to sting or not) of sting challenges and/or field stings will be recorded to identify patients who will not tolerate but react to future stings. These results will be compared between patients not taking antihypertensive (AHT) drugs and patients taking AHT drugs.

  8. Correlation of the Prevalence of Cardiovascular Diseases and/or Hypertension With the Risk for More Frequent Side Effects (=Systemic Reaction, SR) Under VIT.

    Time frame: duration of Visit ~1hour

    To correlate the prevalence of cardiovascular diseases and/or hypertension with the risk for more frequent side effects (=systemic reaction, SR) under VIT..

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Acronym: EADOAS

Important dates

Study start
2014
Primary completion
2018
Study completion
2019
First posted
Feb 17, 2020
Registry last updated
Nov 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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